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Melting point / freezing point

Link to relevant study record(s)

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February 2018 to 30 October 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Deviations:

no

GLP compliance:

yes

Type of method:

method to determine freezing temperature

Specific details on test material used for the study:

Physical Form: Amber liquid
Stability: Stable at room temperature

Key result

Melting / freezing pt.:

< -20 °C

Remarks on result:

other: visual assessment

Freezing Point Observations

Temperature	Sample Appearance
4 °C	Vial inverted, Test Item mobile, i.e. not frozen
-20 °C	Top of Test Item removed, hardened compared to 4°C but still pliable when touched with spatula, i.e. not frozen
-80 °C	Top of Test Item removed, hardened compared to -20°C but still pliable when touched with spatula, i.e. not frozen

 

Conclusions:

The melting point of the test material has been determined to be less than -20 °C.

Executive summary:

The preliminary test indicated a freezing point of < -20 °C for the Test Item. Therefore, a full freezing point determination was not required as described in ECHA Guidance R.7.1.2:

Column 2 of REACH Annex VII provides the following specific rules for adaptation of the standard information requirement for melting point/freezing point.

‘The study does not need to be conducted below a lower limit of -20 °C.’

‘Therefore, Annex 7 to REACH does not require determination of the melting point below a lower limit of -20 °C. The lower limit should be confirmed through testing, except where a (Q)SAR indicates a melting point of -50 °C or lower.’

Description of key information

The melting point of the test material has been determined to be less than -20 °C.